Job Details

ID #12463389
Estado Connecticut
Ciudad New haven
Tipo de trabajo Contract
Salario USD $110000.00 - $110000.00 per annum 110000.00 - 110000.00 per annum
Fuente Experis
Showed 2021-04-21
Fecha 2021-04-21
Fecha tope 2021-06-20
Categoría Etcétera
Crear un currículum vítae

Assistant Director, Quality Assurance

Connecticut, New haven, 06510 New haven USA

Vacancy caducado!

Our client in New Haven, CT, a leader in education and research, is seeking an Assistant Director, Quality Assurance. The Assistant Director is responsible for leading, managing, and advising designated staff, teams, and/or areas within the client (and HRPP as assigned) and is responsible for independently identifying and resolving issues regarding the client and the designated committees it supports. The position works closely with client and HRPP leadership, client and HRPP staff, IRB members, ancillary committee leadership, and others in the University research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact human research. Additionally, the position will:

  • Review, research, and interpret changes, trends and new developments related to human research.
  • Provide written analysis on specified topics.
  • Draft policies and procedures to implement and operationalize client and HRPP-related initiatives.
  • Develop strategies to enable the client and HRPP and other implicated University Departments and personnel to successfully adapt to changes.
  • Serve as a resource to the University community regarding human research matters.
Reporting jointly to the Associate Director, Quality Assurance at the Center for Clinical Investigation (client) and the Director, Human Research Protections Program (HRPP) within the Office of Research Administration (ORA), this position manages the development, implementation and monitoring of an effective clinical research quality assurance program, coordinating the clinical research reviews and monitoring efforts for clinical trials conducted at the Medical School (including the School of Public Health). The position also supports Quality Assurance efforts managed by the HRPP. This includes research conducted outside of the School of Medicine and committees supported by the HRPP office. The position oversees an internal auditing program; the implementation of quality control measures to promote safety and compliance and the integration of QA with multiple review committees. A critical component of the role is to identify to the Directors any safety and compliance concerns and recommend solutions to improve the overall operations, the safe and efficient conduct of clinical trials and educational and training opportunities for faculty and staff.

Essential Duties 1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned.

Required Education and Experience Bachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.

  • Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.
  • Demonstrated ability to manage, organize, and execute complex projects. Ability to multi-task, identify, analyze, and resolve problems efficiently and effectively, to use good, independent judgment and to assess risk. Ability to independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.
  • Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches. Ability to distill and communicate complex information into understandable information.
  • Demonstrated ability to provide guidance regarding regulatory requirements and resolve issues. Ability to be proactive, flexible, and customer service-focused and to work effectively with others. Demonstration of ethics and integrity in professional matters, with sensitivity to confidentiality, and commitment to protecting research participants.
  • Demonstrated technology and software application skills. Ability to learn new software packages. Highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.). Knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms).

Preferred Education, Experience and Skills:

  • Advanced degree preferred (JD, PhD, MD, etc.).
  • Research Compliance, Certified IRB Professional, or other relevant certification.
  • Project, quality, or lean management certification.
  • Experience in a leadership/consultancy role.
  • Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process.
  • Experience with international research standards.

Vacancy caducado!

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